Fibromyalgia Support Group
You're not alone in your pain. Fibromyalgia is a condition that can be difficult to diagnose and manage. If you're trying to cope with pain throughout your body, sleep problems, general fatigue, or other common fibromyalgia symptoms, you're in the right place. The community is here for you to talk about therapies and share your challenges.
Press Release Source: UCB
UCB announces top-line outcomes for proof-of-concept studies
Friday February 20, 1:07 pm ET
BRUSSELS, BELGIUM--(MARKET WIRE)--Feb 20, 2009 --
Lacosamide in migraine prophylaxis and rotigotine in fibromyalgia syndrome did not achieve statistical significance for their primary endpoints
Brussels, Belgium, 20 February 2009 at 6:00 PM (CET) - press release, regulated information - UCB announced today top-line results from two proof-of-concept Phase IIa clinical trials to assess the efficacy and safety of lacosamide in migraine prophylaxis, and the efficacy and safety of rotigotine in fibromyalgia syndrome. These trials were designed to determine whether there is justification for further clinical development of lacosamide and rotigotine in these indications. The respective studies did not achieve statistical significance for their primary endpoints. UCB will evaluate development plans once full analyses are available.
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Phase IIa study: lacosamide in migraine prophylaxis
The multicentre, randomized, double-blind, placebo-controlled trial was designed to evaluate the efficacy of lacosamide (100 mg/day and 300 mg/day) compared to placebo in reducing the frequency of migraine. The primary efficacy variable was the mean reduction of migraine rates during the 14-week maintenance period compared to the average frequency during the 4-week baseline period. Patients in this trial (218) had a history of episodic migraine with or without aura for at least 1 year and a well-documented three month retrospective history of migraines prior to enrolment. The trial did not meet its primary endpoint. However, a reduction in headache frequency was consistently observed in all treatment groups.
Phase IIa study: rotigotine in fibromyalgia syndrome
The multicentre, randomized, double-blind, placebo-controlled trial was designed to investigate the efficacy and safety of rotigotine (4 mg/24 h and 8 mg/24 h) compared to placebo in adult patients (240) with signs and symptoms of fibromyalgia syndrome. The primary efficacy variable was the reduction in pain for patients taking rotigotine as measured by the average Likert pain score at baseline to the last two weeks of the 13 week treatment period. The study results did not achieve statistical significance for its primary endpoint. Only primary efficacy and safety data have been reviewed at this time.
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a biopharmaceutical company dedicated to the research, development and commercialization of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing more than 10 000 people in over 40 countries, UCB aims to achieve revenues of at least EUR3.3 billion in 2008. UCB is listed on Euronext Brussels (symbol: UCB).
About Migraine
Migraine is a common, disabling primary headache disorder. It typically affects one side of the head and may be pulsating, of moderate to severe intensity, and aggravated by routine activity. Migraine headache can last up to two to three days and is commonly accompanied by nausea and vomiting, and/or intolerance to normal levels of light and sound. Migraine is two to three times more common in women than men.
About Fibromyalgia
Fibromyalgia is an idiopathic, chronic, pain syndrome defined by widespread musculoskeletal pain and generalized tender points. Other common symptoms include sleep disturbances, fatigue, headache, morning stiffness and anxiety. Fibromyalgia is usually considered a disorder of women aged 20 to 50 years; however, it has also been observed in men, children, adolescents and older persons. Fibromyalgia is more common in relatives of people with fibromyalgia, suggesting the contribution of genetic factors.
Forward looking statement
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.
For the pdf version of this press release, please click on the link below:
http://hugin.info/133973/R/1292262/292293.pdf
This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Copyright Hugin AS 2009. All rights reserved.
UCB announces top-line outcomes for proof-of-concept studies
Friday February 20, 1:07 pm ET
BRUSSELS, BELGIUM--(MARKET WIRE)--Feb 20, 2009 --
Lacosamide in migraine prophylaxis and rotigotine in fibromyalgia syndrome did not achieve statistical significance for their primary endpoints
Brussels, Belgium, 20 February 2009 at 6:00 PM (CET) - press release, regulated information - UCB announced today top-line results from two proof-of-concept Phase IIa clinical trials to assess the efficacy and safety of lacosamide in migraine prophylaxis, and the efficacy and safety of rotigotine in fibromyalgia syndrome. These trials were designed to determine whether there is justification for further clinical development of lacosamide and rotigotine in these indications. The respective studies did not achieve statistical significance for their primary endpoints. UCB will evaluate development plans once full analyses are available.
ADVERTISEMENT
Phase IIa study: lacosamide in migraine prophylaxis
The multicentre, randomized, double-blind, placebo-controlled trial was designed to evaluate the efficacy of lacosamide (100 mg/day and 300 mg/day) compared to placebo in reducing the frequency of migraine. The primary efficacy variable was the mean reduction of migraine rates during the 14-week maintenance period compared to the average frequency during the 4-week baseline period. Patients in this trial (218) had a history of episodic migraine with or without aura for at least 1 year and a well-documented three month retrospective history of migraines prior to enrolment. The trial did not meet its primary endpoint. However, a reduction in headache frequency was consistently observed in all treatment groups.
Phase IIa study: rotigotine in fibromyalgia syndrome
The multicentre, randomized, double-blind, placebo-controlled trial was designed to investigate the efficacy and safety of rotigotine (4 mg/24 h and 8 mg/24 h) compared to placebo in adult patients (240) with signs and symptoms of fibromyalgia syndrome. The primary efficacy variable was the reduction in pain for patients taking rotigotine as measured by the average Likert pain score at baseline to the last two weeks of the 13 week treatment period. The study results did not achieve statistical significance for its primary endpoint. Only primary efficacy and safety data have been reviewed at this time.
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a biopharmaceutical company dedicated to the research, development and commercialization of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing more than 10 000 people in over 40 countries, UCB aims to achieve revenues of at least EUR3.3 billion in 2008. UCB is listed on Euronext Brussels (symbol: UCB).
About Migraine
Migraine is a common, disabling primary headache disorder. It typically affects one side of the head and may be pulsating, of moderate to severe intensity, and aggravated by routine activity. Migraine headache can last up to two to three days and is commonly accompanied by nausea and vomiting, and/or intolerance to normal levels of light and sound. Migraine is two to three times more common in women than men.
About Fibromyalgia
Fibromyalgia is an idiopathic, chronic, pain syndrome defined by widespread musculoskeletal pain and generalized tender points. Other common symptoms include sleep disturbances, fatigue, headache, morning stiffness and anxiety. Fibromyalgia is usually considered a disorder of women aged 20 to 50 years; however, it has also been observed in men, children, adolescents and older persons. Fibromyalgia is more common in relatives of people with fibromyalgia, suggesting the contribution of genetic factors.
Forward looking statement
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.
For the pdf version of this press release, please click on the link below:
http://hugin.info/133973/R/1292262/292293.pdf
This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Copyright Hugin AS 2009. All rights reserved.
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A friend sent this to me..As far as I can see, grief will never truly end.It may become softer overtime, more gentleand some days will feel sharp.But grief will last as long as Love does - ForeverIt's simply the way the absence of your loved onemanifests in your heart. A deep longing accompaniedby the deepest Love some days. The heavy fog mayreturn and the next day, it may recede.Once again, it's...
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Today is my 25th birthday, to my somewhat lack of surprise I can see already no one really seems to care. I've always been the kinda person to make sure that everyone I Care about feels appreciated and knew somebody had their back. I can count 4 times this year when I Went out of my way to make sure a "friend" felt good on their birthday, especially if they got left hanging. Its early in the...
Lacosamide also known as Vimpat is an anti seizure med.
http://www.drugs.com/cdi/lacosamide-tablets.html
Rotigotine brand name Neupro is an anti-parkinsonian treatment.
http://www.drugs.com/cdi/rotigotine.html
it looks as though they are going the route of treating the nerve pathways to help fight the pain for fibro. Lyrica is the newest approved drug for fibro treatment, while Neurontin is a similar, generic, and less expensive type of this med. The other approved drug for fibro is Cymbalta which is an antidepressant which is also suppose to help with pain relief. It is a SSNRI (selective serotonin neurepinephrine reuptake inhibitor) like combining Pazil or Prozac or Lexapro type antidepressant with the antidepressant Wellbutrin (Buproprione).